title: Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study.
abstract: BACKGROUND
  Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of COPD.
  
  
  METHODS
  This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg twice-daily in patients with moderate-to-severe COPD. Assessments included FEV(1) standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV(1) (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV(1) and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use.
  
  
  RESULTS
  Of 1123 patients randomised 92.1% completed. Mean ± SD age was 62.8±8.78 years, post-bronchodilator FEV(1) 51.8±12.32% predicted, FEV(1)/FVC 50.6±9.54%. At Week 12, FEV(1) AUC(5 min-11 h 45 min) for indacaterol was statistically superior (p<0.001) to salmeterol (adjusted mean difference [95% CI] 57 [35, 79] mL), as was 24-h trough FEV(1) (60 [37, 83] mL, p<0.001). Indacaterol also showed statistical superiority over salmeterol in terms of FEV(1) and FVC measured over 24-h at Week 12. For TDI at Week 12, the mean total score was statistically superior for indacaterol versus salmeterol (difference 0.63 [0.30, 0.97], p<0.001), as was the percentage of patients with a clinically relevant (i.e., ≥1 point) change from baseline (69.4% vs 62.7%, p<0.05). For rescue medication, patients on indacaterol used fewer puffs/day (difference -0.18 [-0.36, 0.00] puffs/day, p<0.05) and had a greater percentage of days with no rescue use (difference 4.4 [0.6, 8.2], p<0.05).
  
  
  CONCLUSIONS
  Once-daily indacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093.
authors.affiliation: Pulmonary Department, Mainz University Hospital, Mainz, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Korn
authors.forename: Edward
authors.initials: E
authors.lastname: Kerwin
authors.forename: Sibel
authors.initials: S
authors.lastname: Atis
authors.forename: Carolynn
authors.initials: C
authors.lastname: Amos
authors.forename: Roger
authors.initials: R
authors.lastname: Owen
authors.forename: Cheryl
authors.initials: C
authors.lastname: Lassen
mesh_terms: D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage*; D012129:Respiratory Function Tests / Q000379:methods; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; D000068299:Salmeterol Xinafoate; C510790:indacaterol; D000420:Albuterol